Clinical Evaluation Reports

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Clinical
Evaluation Report
www.mavenprofserv.com
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CONTENT
Clinical Evaluation Report MEDDEV 2.7/1 Rev 4
Guideline FAQ
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CLINICAL EVALUATION REPORT
Clinical evaluation report (CER) summarizes and
concludes the clinical evaluation of medical
devices. Clinical evaluation is responsibility
of the manufacturer and is a critical step in
process of CE Marking. Many manufacturers
struggle and find it tedious to comply with the
requirements of CER.
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If manufacturers want to place your devices in
European Market, they must prepare and maintain
a clinical evaluation report that complies with
the requirements of MEDDEV 2.7.1. rev. 4 and EU
MDR Article 61 and Annex XIV part A. Maven
Profcon Services LLP. has a team of experienced
professionals who are well versed with the CE
regulations and literature reviews to compile
your CER.
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In accordance with the European regulation, the
clinical evaluation and the clinical evaluation
report must be actively updated with data
obtained from post-market surveillance.
All clinical data sets shall be documented, adequa
tely summarised, appraised, analysed and refer
enced) in the be
clinical evaluation report. The appraisal should
documented in the clinical evaluation report to th
e extent that it can be critically reviewed by
others.
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Clinical evaluation report shall also include
current state of art and clinical background of
the device and the evaluators should check the
clinical evaluation report, provide verification
that it includes an accurate statement of their
analysis and opinions, and sign the clinical
evaluation report.
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MEDDEV 2.7/1 Rev 4 Guideline
The MEDDEV 2.7/1 Rev 4 guidelines, released in
June 2016, provide updated guidance on clinical
evaluation for the medical device manufacturers
and noticed bodies under directives 93/42/EEC
and 90/385/EEC. The latest revision (Rev 4)
effectively replaces Rev 3 published in December
2009. While the ideology of evaluating clinical
evidence to demonstrate compliance with relevant
Essential Requirements remains unchanged, the
Rev 4 guidelines detail the requirement for
clinical evaluation.
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FAQ
1. What is clinical evaluation? Clinical
evaluation a methodologically sound ongoing
procedure to collect, appraise and analyse
clinical data pertaining to a medical device and
to evaluate whether there is sufficient clinical
evidence to confirm compliance with relevant
general safety and performance requirements for
safety and performance when using the device
according to the manufacturers Instructions for
Use.
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2. Who can perform the clinical
evaluation? It has been mentioned clearly in sect
ion 6.4 of MEDDEV
guideline for clinical evaluation that
consider certain aspects in selecting
manufacturer should the evaluators and
justifying the same. Certain aspects need to be
considered while selecting a evaluator
are Evaluators should possess a knowledge and
experience in research methodology and systemic
search strategy using certain databases.
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Prior knowledge in regulatory requirements and in
medical writing where experts in systemic
reviewing of the literature and clinical data
appraisal Knowledge of device technology and its
application A degree from respective field and 5
years documented professional experience or 10
years of documented professional experience if
degree is not a pre-requisite.
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3. What is difference between clinical evaluation
and clinical investigation? Clinical
investigation is systematic investigation in one
or more human subjects, to assess the safety or
performance of a medical device and Clinical
evaluation of medical devices is a systematic
and planned process that contributes to the
continuous generation, collection, analysis and
evaluation of clinical data on a particular
device.
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